Layered Process Audits (LPAs) involve a large percentage of the employees in the auditing process instead of restricting it only to the quality team. Moreover, LPAs are designed so quality can be checked every step along the way – right from the design stage to when the finished product is ready to be shipped out.
The supervisors of the different teams are responsible for conducting periodic process audits within their functional areas while senior managers audit a broader range of areas (but less frequently). ‘Layers’ refers to the audit being conducted across various levels of the organization, spanning several departments and processes.
With LPAs, manufacturers can:
- Assume greater control over various processes
- Take quick corrective/preventive action at all layers
- Reduce mistakes and nonconformances
- Improve the overall quality of work & enhance quality performance
- Increase revenues
- Reduce total cost of quality
Layered audits have been commonly used in the automotive and aerospace industries, thanks to their emphasis on Total Quality Management (TQM) and Total Employee Involvement (TEI).
Today, LPAs are being adopted in other sectors including medical device, pharma & biotech, chemicals and other process industries, consumer packaged goods, and hi-tech.
Are you looking to build an enterprise-wide quality culture? Do you want to bring in Total Employee Involvement (TEI) to drive quality maturity and continuous improvement? Layered Audits is one process that’ll really help. Read this whitepaper to find out more.
The Audit Questionnaire
The audit involves answering up to 10 short ‘yes or no’ questions related to a process and takes less than 15 minutes to complete. More like a checklist, the LPA enables a risk-based strategy that helps with ensuring that the process aligns to relevant standards, facilitates continuous improvement, and enables identifying high-risk inputs at the beginning of each shift. This synchronizes with the Plan-Do-Check-Act approach and it emphasizes the need for a quality-first approach across all processes or ‘layers’.
Learn about the LPA process, identify the ‘audit’ team, create questions, determine audit layers
Well-planned scheduling of audits; ensure there is a closed-loop system such that findings from an audit is communicated to the relevant team for any fixes to be done
Use next-generation dashboards, data, trends charts and predictive analytics to draw insights from audits
Take corrective/preventive action, drive continuous improvement, take efforts for risk mitigation, etc. Update audit questionnaires as needed
By using LPAs, manufacturers focus on parameters, settings, or behaviors to verify critical inputs of high-risk processes and identify potential nonconformances. The idea behind the LPAs is not to penalize for mistakes but to encourage collaboration resulting in meaningful improvements.
This plays a key role in improving overall quality maturity of an enterprise, and the feedback loop is critical to driving continuous improvement. Also, it is important to note here that a well-designed LPA will focus on high-risk items. The audit questionnaires from various “layers” will bring to the fore key data points and qualitative inputs to understand the key contributors to these risks.
To ensure process standardization, manufacturers need to invest time and resources and drive it top-down. This can be achieved by:
- Creating a cross-functional team of internal auditors representing all levels of management
- Creating a set of simple audits that is focused on high-risk processes and does not need specialized knowledge
- Creating a system for reporting and follow-up to identify and share information on areas that need improvement, and, ensure that corrective and preventive actions are taken
A next-generation cloud-based EQMS can help automate the entire LPA process, right from scheduling to closing the loop, enabling analytics, and continuous improvement.
ComplianceQuest’s Salesforce-based EQMS software is an ideal solution for LPA workflow automation. It can act as a repository for all kinds of checklists, which will help the different functional heads to access, record, and store their observations. Any changes needed, based on customer or regulatory requirements can be centralized to control versions.
Moreover, the different modules of EQMS automatically fit the LPA purpose. These include:
- Audit – You can schedule and track your LPAs across the enterprise
- CAPA – Initiate CAPA for the identified issues
- Change – Track the impact of changes
- Complaints – Integrate customer feedback into the system to prevent future issues
- Document – Record observations, reports, and results
- Equipment – Schedule maintenance and audits
- Inspection – Schedule and track inspections
- Nonconformance – Identify and address nonconformances across functions
- Risk – Manage operational risk tracking, evaluation, mitigation, and monitoring
- Supplier – Ensure supplies that meet specifications and manage your suppliers from onboarding to re-training
- Training – Empower your team with the skills they need to discharge their responsibilities effectively
To know more about ComplianceQuest EQMS and how it can be used to run a layered audit process, request for a demo here: https://www.compliancequest.com/online-demo